Navigation Links
IDM Pharma Receives Not Approvable Letter for Mifamurtide (L-MTP-PE) for the Treatment of Osteosarcoma
Date:8/27/2007

ents with metastatic or unresectable osteosarcoma, 39 of whom received L-MTP-PE, in the controlled Phase 3 trial conducted by the Pediatric Oncology Group (POG) and the Children's Cancer Group (CCG), now the Children's Oncology Group (COG), sponsored by the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute. Also included are safety and efficacy data from 51 patients with metastatic osteosarcoma treated in earlier Phase 2 studies. The biological effects and safety of L-MTP-PE are further supported by data from 7 other Phase 1 and 2 clinical studies performed under IND, in which an additional 197 patients received at least one dose of L-MTP-PE.

L-MTP-PE stimulates the innate immune system (the body's first line of defense) to kill tumor cells. When administered in combination with chemotherapy and after tumor resection to osteosarcoma patients in the Phase 3 trial, L-MTP-PE provided a significant improvement in Disease Free Survival (DFS) (p = 0.0245) and Overall Survival (OS) (p = 0.0183). At 6 years, the probability of survival when L-MTP-PE is combined with adjuvant chemotherapy is 77% (95%CI: 72-83%) compared to 66% (95%CI: 59-73%) without L-MTP-PE, a clinically meaningful finding in a pediatric population where the longer the survival, the greater the chance the patient is cured of cancer.

Treatment with L-MTP-PE was generally well tolerated in all phases of study. Adverse events were mild to moderate in severity and included chills, fever, nausea, vomiting, myalgia, headache, tachycardia (fast heart rate), hypo- and hypertension, fatigue and shortness of breath, all of which are consistent events with the activation of monocytes and macrophages by L-MTP-PE and the flu-like symptoms that follow cytokine release.

L-MTP-PE was granted orphan drug status in the United States in 2001. The NDA for L-MTP-PE was submitted to the FDA in October 2006 and was accepted on December 26, 2006.

In May 2007, the FDA's Oncologic Dru
'/>"/>

SOURCE IDM Pharma, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related biology technology :

1. Analyzing Trace-Level Impurities of a Pharmaceutical Intermediate Using an LCQ Deca Ion Trap Mass Spectrometer and the Mass Frontier Software Package
2. Rapid SNP Genotyping of the Pharmacogenomically Important Allele CYP2D6*4 Using Real-Time qPCR on the DNA Engine Opticon 2 System
3. Development of a sensitive enzyme fragment complementation assay for cyclic adenosine 3, 5 monophosphate and its validation for pharmacological screening at G protein-coupled receptors
4. Practical Applications of HyperDSC in a Pharmaceutical Laboratory
5. World Class Life Science and Pharmaceutical Companies Leverage DoveBid s Global Reach for Asset Management and Disposition
6. Germantown drug company hires pharma veteran James Davidson as COO
7. Deltanoid Pharmaceuticals begins phase II osteoporosis study
8. New angel capital centered on GenTel agreement with big pharma
9. The deconstruction of Big Pharma
10. Big pharma seeks Wisconsin biotech partnerships
11. Doing the pharmaceutical tango
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/29/2015)... ... 2015 , ... The global microfluidics market is expected to ... to 2020). The market is mainly driven by the rising geriatric population, growing ... lack of adequate healthcare and research infrastructure in emerging markets, dearth of skilled ...
(Date:6/29/2015)... , June 29, 2015  AACC, a global ... health through laboratory medicine, is pleased to announce ... Clinical Chemistry , has increased to 7.9 in ... increase places Clinical Chemistry in the ... the significant influence of the research it publishes ...
(Date:6/29/2015)... GERMANTOWN, Md. , June 29, 2015  Neuralstem, ... stem cell technology to develop small molecule and cell ... that it has been approved for listing on the ... common stock will continue to trade on the NYSE ... Trading on the NASDAQ Capital Market is expected to ...
(Date:6/29/2015)... ... ... The StampedeCon 2015 Big Data Conference will be taking place ... will bring top technology professionals to St. Louis. Top industry speakers will share their ... The event is proudly sponsored by DataStax, Cisco, World Wide Technology, Hortonworks, OCI, HP, ...
Breaking Biology Technology:Microfluidics Market Growing at 19.3% CAGR To 2020 – New research available at ReportsnReports.com 2Microfluidics Market Growing at 19.3% CAGR To 2020 – New research available at ReportsnReports.com 3Microfluidics Market Growing at 19.3% CAGR To 2020 – New research available at ReportsnReports.com 4Microfluidics Market Growing at 19.3% CAGR To 2020 – New research available at ReportsnReports.com 5AACC's Journal, Clinical Chemistry, Continues to Have Significant Impact on Medical Testing, Healthcare 2AACC's Journal, Clinical Chemistry, Continues to Have Significant Impact on Medical Testing, Healthcare 3Neuralstem, Inc. Announces Approval for Listing on the NASDAQ Capital Market 2Neuralstem, Inc. Announces Approval for Listing on the NASDAQ Capital Market 3StampedeCon Announces 2015 Agenda 2StampedeCon Announces 2015 Agenda 3
... PRINCETON, N.J., May 13, 2011 Soligenix, Inc. (OTCBB: ... announced today its financial results for the first quarter ... first quarter of 2011 were approximately $808,000 as compared ... increased revenues were primarily a result of increases in ...
... Texas at Austin,s Cockrell School of Engineering have created ... as a greatly enhanced supercapacitor, holding promise for energy ... to consumer electronics. The findings of the group, ... S. Ruoff, will be published May 12 by ...
... Dan Neumeister, FACHE, principal of Neumeister Healthcare Management Services ... selected by Chase Brexton Health Services (CBHS) of Baltimore, ... effective May 1, 2011. Neumeister is serving in this ... fills the position. As CBHS,s top ...
Cached Biology Technology:Soligenix Reports First Quarter 2011 Financial Results and Reviews Accomplishments 2Soligenix Reports First Quarter 2011 Financial Results and Reviews Accomplishments 3Soligenix Reports First Quarter 2011 Financial Results and Reviews Accomplishments 4Soligenix Reports First Quarter 2011 Financial Results and Reviews Accomplishments 5Enhanced electrical energy storage may result from professor's research 2Regional Healthcare Management Firm Goes National 2
(Date:6/30/2015)... YORK , June 30, 2015 To bolster ... security provider HYPR Corp. announced today the addition of two ... will serve as board advisor and David Raviv ... the team underscore HYPR Corp.,s commitment to providing the most ... Dimitri Sirota co-founded Layer 7 Technologies, a provider ...
(Date:6/30/2015)... , June 30, 2015 Genisphere ... as CEO to help further develop Genisphere,s therapeutics capabilities ... partnering experience, having spent much of the last 25 ... Amgen, Baxter Bioscience, and Johnson & Johnson. Tom started ... Technology and Biotech Corporate Finance. He graduated from Dartmouth ...
(Date:6/29/2015)... Research and Markets( http://www.researchandmarkets.com/research/zj7h4f/latin_america ) has ... Sensors Market - Growth, Trends & Forecasts (2014-2020)" ... Biomedical Sensors market is estimated at $0.65 billion by ... 2014-2020 The near future will bring Biomedical ... each individual. These sensors can be set to trigger ...
Breaking Biology News(10 mins):HYPR Corp. Expands Biometric Authentication Team with Enterprise All Stars 2HYPR Corp. Expands Biometric Authentication Team with Enterprise All Stars 3Genisphere Appoints New CEO, Thomas Bliss 2Genisphere Appoints New CEO, Thomas Bliss 3Latin America Biomedical Sensors Market Report 2015-2020 2
... Cold Spring Harbor Laboratory (CSHL) today announced the launch ... communication -- a new, free service, called bioRxiv (pronounced "bio-Archive"). ... to share the results of their work before peer review ... reading its contents costs nothing. Each paper is given ...
... Virginia: November 12, 2013: An invention that strips cancer ... a better way to shock hearts back into their normal ... inventing competition. "We had a fantastic diversity of creative ... Competition judge almost as hard as being an inventor," said ...
... of energy from as many photons as possible is ... and electronic engineering researchers on a quest to boost ... are now running up against limits set by the ... the University of Pennsylvania and Drexel University have experimentally ...
Cached Biology News:CSHL launches bioRxiv, a freely accessible, citable preprint server for biology 2Cancer can't hide; better heart shocks; mechanical leeches 2Penn and Drexel team demonstrates new paradigm for solar cell construction 2Penn and Drexel team demonstrates new paradigm for solar cell construction 3Penn and Drexel team demonstrates new paradigm for solar cell construction 4Penn and Drexel team demonstrates new paradigm for solar cell construction 5
... new technology incorporating the sophisticated DirectDrive ... the new Varian NMR System is ... today., ,The Varian NMR System features ... receiver channel, providing pulse sequence programming ...
... vitro cell labeling mix, 92.5 ... solution stabilized with 0.1% 2-mercaptoethanol ... 3,4-dicarboxylic acid. *Amino acid mixture ... containing l-[35S]Methionine and l-[35S]Cysteine. * ...
... Assay, 96 wells. ELISA.Specific for total ... MMP-3. No cross-reactivity with MMP-1, -2, -9. ... use with cell culture supernatant, serum, plasma ... to -30 C. Category: Drug Screening ...
... for serial preparation of ... including cytosol/particulate/cytoskeleton/nuclear fractions from ... fractions can directly be ... such as 2-D gel/Western ...
Biology Products: